The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers

January 30, 2017 updated by: Lo Kwok Man, Our Lady of Maryknoll Hospital

The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for the Treatment of Pressure Ulcers

To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and HMB for a maximum period of four weeks is more beneficial than the standard dietary approach to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions and length of hospitalizations for these patients.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given. Nutritional supplement other than that provided by the dietitian to meet the energy and protein requirement would not be given. The pressure ulcers would be cared according to the "Basic nursing standards for patient care: Wound dressing - Version 5" published by the Hospital Authority Head Office.

The treatment group would also be given 2 Sackets of a mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ka Ying Doris Miu, FHKAM (Med)

Study Locations

      • Wong Tai Sin, Hong Kong, 852
        • Recruiting
        • Our Lady of Maryknoll Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Inpatients of medical and geriatric wards of OLMH and WTSH
  2. Aged 18 and older with stage III - IV lesions
  3. Patients fed orally or through feeding tubes were included

Exclusion Criteria:

  1. Patients with history of using the nutritional supplement (ABOUND) in previous three months
  2. Patients with cellulitis, wounds with purulent discharge or osteomyelitis or sepsis
  3. Patients requiring protein restriction
  4. Patients with poorly controlled diabetes mellitus (latest HbA1C > 8.5) (healing process may be affected
  5. Patients under palliative care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study group
The treatment group would be given 2 Sackets of an oral mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.
an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate
NO_INTERVENTION: Control group
All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage change in pressure ulcer area
Time Frame: 4 weeks
4 weeks
change in Pressure Ulcer Scale for Healing (PUSH)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
number of hospital admissions
Time Frame: six months
six months
length of hospitalisation
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ANTICIPATED)

September 30, 2019

Study Completion (ANTICIPATED)

March 31, 2020

Study Registration Dates

First Submitted

January 28, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (ESTIMATE)

January 31, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • KW/FR-16-167(104-04)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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